Vascular Access Assembly and Safety Device

ABSTRACT

A safety intravenous (IV) catheter assembly is disclosed which includes a safety device having a housing defining a cavity and distal and proximal openings, and a biasing member positioned within the cavity. The biasing member is movable from a first position to a second position to tilt the housing in relation to the needle when the needle tip is withdrawn through the distal opening of the housing to misalign the needle tip and the distal opening. A blocking arm is provided on the biasing member to prevent the biasing member from moving from the second position back to the first position.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.13/651,979 which claims priority to, and the benefit of, U.S.Provisional Patent Application No. 61/547,410, filed on Oct. 14, 2011,the entire contents of each of which are hereby incorporated byreference.

BACKGROUND

1. Technical Field

The present disclosure relates to intravenous (“IV”) catheter assembliesfor vascular access, and more particularly to safety IV catheterassemblies for vascular access which include a needle tip guard forprotecting a clinician from accidental needle stick injuries.

2. Background of Related Art

IV catheter assemblies are utilized in a variety of medical applicationsfor supplying or withdrawing fluid to or from a body vessel. Generally,IV catheter assemblies include an external cannula for indwelling in ablood vessel of a patient and an internal needle that is inserted intothe external cannula to facilitate piercing of the blood vessel of thepatient. In operation of the IV catheter assembly, the internal needleis inserted into the external cannula such that the tip portion of theinternal needle protrudes from a tip portion of the external cannula.Next, the internal needle is manipulated to pierce a blood vessel and toposition the external cannula within the blood vessel. While theexternal cannula is positioned within the blood vessel, the internalneedle is withdrawn from the external cannula leaving the externalcannula positioned within the blood vessel. In this position, a medicaldevice can be connected to the rear end portion of the external cannulausing, for example, a luer connector, to facilitate the supply andwithdrawal of fluid, such as blood, medication and/or nutrients, to orfrom the blood vessel.

After the internal needle is withdrawn from the external cannula, theexposed needle tip of the internal needle creates a danger of accidentalneedle stick injury which can leave a clinician vulnerable to thetransmission of various blood-borne pathogens, such as HIV andhepatitis. While needle tip protectors have been developed to protectthe clinician from needle stick injuries, the cost, ease of use, andeffectiveness of these needle tip protectors leaves room forimprovement.

Accordingly, it would be beneficial to provide a safety IV catheterassembly which is easily activated by a clinician, effectively protectsa clinician from accidental needle stick injury and is economical toproduce.

SUMMARY

A safety intravenous catheter assembly is disclosed which comprises aneedle assembly, a catheter assembly and a safety device. The needleassembly includes a needle hub and a needle having a proximal endsecured to the needle hub and a distal end defining a tip. The catheterassembly includes a catheter hub and a catheter tube extending distallyfrom the catheter hub, and the safety device includes a housing defininga cavity, a distal opening and a proximal opening and a biasing membersupported within the cavity. The distal and proximal openings aredimensioned to receive the needle. The biasing member includes astationary portion, a movable portion and a blocking arm. The movableportion is movable in relation to the stationary portion from a firstposition to a second position. In an assembled state, the safety deviceis positioned between the needle hub and the catheter hub, the needleextends through the proximal and distal openings of the housing of thesafety device and the catheter assembly, and the biasing member iscompressed between the needle and the housing such that the movableportion is in the first position in engagement with the needle. In adisassembled state, the tip of the needle is withdrawn through thedistal opening into the cavity of the housing of the safety device andthe movable portion of the biasing member is in the second positionspaced further outwardly of the stationary portion such that the housingis tilted in relation to the needle. In the tilted position, the needleis moved out of alignment with the distal opening of the housing. In thedisassembled state, the blocking arm is positioned between the movableportion and the stationary portion to prevent movement of the movableportion from the second position back to the first position.

In one embodiment, the housing includes at least one post extending fromone side of the housing across the cavity which is positioned to engagethe stationary portion of the biasing member to secure the position ofthe biasing member within the housing.

The housing of the safety device may include a finger configured toreleasably engage the catheter hub. The finger includes radialprojection which is configured to be received in a recess formed in thecatheter hub to releasably secure the safety device to the catheter hub.

In one embodiment, the biasing member is unitarily formed from aresilient material such as spring steel.

The needle hub may include a tab and the housing of the safety devicemay define a cutout positioned to receive the tab in the assembled stateto properly orient the safety device in relation to the needle hub.

In one embodiment, the housing is formed from molded half-sections, andthe at least one post is formed on one of the half-sections and extendsacross the cavity towards a sidewall of the other of the half-sections.

The proximal end of the catheter hub may include a luer connector.

In one embodiment, the portion of the movable portion of the biasingmember in engagement with the needle may be formed of or covered with amaterial having a low coefficient of friction. In one embodiment, themovable portion of the biasing member is at least partially covered by aUV cured adhesive.

The biasing member may include spring fingers which are received withina channel formed in the housing to secure the biasing member within thehousing.

In one embodiment, the stationary portion of the biasing member definesat least one opening to receive a post formed in the housing to properlyalign the biasing member within the housing.

A safety device is also disclosed which comprises a housing defining acavity having a distal opening and a proximal opening. The distal andproximal openings are dimensioned to receive a needle of an intravenouscatheter assembly. A biasing member is supported within the cavity andincludes, a stationary portion, a movable portion, and a blocking arm.The movable portion is movable from a first position in which thebiasing member is compressed between the needle and the housing to asecond position in which the movable portion is spaced further outwardlyof the stationary portion to tilt the housing in relation to the needleand move the needle out of alignment with the distal opening of thehousing. In the second position, the blocking arm of the movable portionis positioned to prevent movement of the movable portion back to thefirst position.

In one embodiment, the housing includes at least one post extending fromone side of the housing across the cavity which is positioned to engagethe stationary portion of the biasing member.

The housing of the safety device may include a finger configured toreleasably engage a catheter hub which includes radial projection whichis configured to be received in a recess formed in the catheter hub toreleasably secure the safety device to the catheter hub.

In one embodiment, the biasing member is unitarily formed from aresilient material such as spring steel.

In one embodiment, the housing of the safety device defines a cutoutpositioned to receive a tab formed on a needle hub to properly orientthe safety device in relation to the needle hub.

In one embodiment, the housing is formed from molded half-sections.

In one embodiment, the portion of the movable portion of the biasingmember in engagement with the needle may include or be covered with amaterial having a low coefficient of friction. In one embodiment, thematerial may include an UV cured adhesive.

In one embodiment, the biasing member includes spring fingers which arereceived within a channel formed in the housing to secure the biasingmember within the housing.

The stationary portion of the biasing member may define at least oneopening dimensioned to receive a post formed in the housing to properlyalign the biasing member within the housing.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed safety IV catheterassembly will be described herein with references to the accompanyingdrawings, wherein:

FIG. 1 is a side view of one embodiment of the presently disclosedsafety IV catheter assembly in an assembled state with the portion ofthe biasing member and needle positioned within the safety devicehousing shown in phantom;

FIG. 1A is a side cross-sectional view of the safety IV catheterassembly shown in FIG. 1;

FIG. 2A is a perspective view from one side of a half-section of thesafety device housing of the safety IV catheter assembly shown in FIG.1;

FIG. 2B is a perspective view from the other side of the half-section ofthe safety device housing shown in FIG. 2A;

FIG. 3A is a perspective view of the biasing member of the safety IVcatheter assembly shown in FIG. 1;

FIGS. 3 and 4 are side perspective views of the safety IV catheterassembly shown in FIG. 1 in an assembled state with the portion of thebiasing member and needle positioned within the safety device housingshown in phantom;

FIG. 5 is a side view of the safety IV catheter assembly shown in FIG. 4with the portion of the needle and biasing member within the safetydevice housing shown in phantom;

FIG. 6 is a side view of the safety IV catheter assembly shown in FIG. 1in a disassembled state with the safety device supported on the distalend of the needle and the portion of the biasing member and needlewithin the safety device housing shown in phantom;

FIG. 7 is an enlarged, side, perspective view of the safety device ofthe safety IV catheter assembly shown in FIG. 6 supported on a distalend of the needle with the portion of the biasing member and needlepositioned within the safety device housing shown in phantom;

FIG. 8 is a perspective view from the proximal end of the safety IVcatheter assembly shown in FIG. 6 in a disassembled state with theportion of the biasing member and needle tip shown in phantom within thesafety device housing;

FIG. 9 is a side, partial perspective view of the safety IV catheterassembly shown in FIG. 6 in a disassembled state with the portion of thebiasing member and the needle tip shown in phantom within the safetydevice housing;

FIG. 10 is a side cross-sectional view of the needle assembly and safetydevice of the safety IV catheter assembly shown in FIG. 6 with thesafety device supported on the tip of the needle;

FIG. 11 is a transverse, cross-sectional view through the safety deviceshown in FIG. 10 with the safety device supported on the tip of theneedle;

FIG. 12 is an enlarged view of the indicated area of detail shown inFIG. 10;

FIG. 13 is a side view of the biasing member of the safety IV catheterassembly shown in FIG. 10 in its undeformed state;

FIG. 14 is a side cross-sectional view of another embodiment of thepresently disclosed safety IV catheter assembly in an assembled state;

FIG. 15 is a cross-sectional view taken along section lines 15-15 ofFIG. 14;

FIG. 16 is a transverse cross-sectional view taken along section lines16-16 of FIG. 14;

FIG. 17 is a side perspective view of the biasing member of the safetyIV catheter assembly shown in FIG. 14 with the movable portion in itsbiased position;

FIG. 17A is a cross-sectional view taken along section lines 17A-17A ofFIG. 17;

FIG. 18 is a side cross-sectional view of the safety IV catheterassembly in a disassembled state with the safety device supported on thedistal end of the needle;

FIG. 19 is an enlarged view of the indicated area of detail shown inFIG. 18;

FIG. 20 is a cross-sectional view taken along section lines 20-20 ofFIG. 19;

FIG. 21 is a side cross-sectional view of the safety IV catheterassembly shown in FIG. 14 immediately prior to withdrawal of the needletip through the distal opening of the housing of the safety device andprior to separation of the safety device from the catheter hub;

FIG. 22 is a side perspective view from the distal end of anotheralternate embodiment of the presently disclosed safety IV catheterassembly with a safety cover supported about the safety device andcatheter assembly;

FIG. 23 is a top side perspective view from the proximal end of thesafety IV catheter assembly shown in FIG. 22;

FIG. 24 is a bottom, perspective view from the proximal end of thesafety IV catheter assembly shown in FIG. 22;

FIG. 25 is a top, perspective view from the distal end of the safety IVcatheter shown in FIG. 22 with the safety cover separated from the IVcatheter assembly;

FIG. 26 is a side perspective view of the safety IV catheter assemblyshown in FIG. 25 with the safety cover removed;

FIG. 27 is an enlarged perspective view of the indicated area of detailshown in FIG. 26;

FIG. 28 is a side perspective view of the safety IV catheter assemblyshown in FIG. 26 with parts separated;

FIG. 29 is a top, perspective view of the biasing member of the safetydevice of the IV catheter assembly shown in FIG. 28;

FIG. 30 is a side perspective view of a housing half-section of thesafety device shown in FIG. 28 with the biasing member removed;

FIG. 31 is a side perspective view of the housing half-section shown inFIG. 30 with the biasing member positioned in the housing half-section;

FIG. 32 is a side perspective view of the IV catheter assembly shown inFIG. 26 in an assembled state with one housing half-section removed fromthe safety device;

FIG. 33 is a side perspective view of the IV catheter assembly shown inFIG. 32 with the other housing half-section removed from the safetydevice;

FIG. 34 is a side cross-sectional view of the IV catheter assembly andsafety cover taken along section lines 34-34 of FIG. 23;

FIG. 35 is an enlarged view of the indicated area of detail shown inFIG. 34;

FIG. 36 is a cross-sectional view taken along section lines 36-36 ofFIG. 35;

FIG. 37 is a side, perspective view of the IV catheter assembly with theneedle assembly withdrawn from the catheter assembly and the safetydevice supported on the needle tip;

FIG. 37A is a side view of the needle assembly shown in FIG. 37 with thesafety device supported on the needle tip;

FIG. 37B is an enlarged view of the indicated area of detail shown inFIG. 37 a;

FIG. 38 is a side perspective view of the distal end of the needle withthe needle tip positioned within the safety device housing with ahousing half-section of the safety device removed;

FIG. 39 is a side-partial cross-sectional view of the safety device anddistal end of the needle of the safety IV catheter assembly shown inFIG. 38; and

FIG. 40 is a cross-sectional view taken along section lines 40-40 ofFIG. 39.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed safety IV catheter assembly willnow be described in detail with reference to the drawings wherein likereference numerals designate identical or corresponding elements in eachof the several views. In this description, the term “proximal” isgenerally used to refer to the portion of the device that is closer to aclinician, while the term “distal” is generally used to refer to theportion of the device that is farther from the clinician. As usedherein, the term “patient” should be understood as referring to a humanpatient or other animal, and the term “clinician” should be understoodas referring to a doctor, nurse or other care provider and may includesupport personnel.

FIGS. 1-13 illustrate one embodiment of the presently disclosed safetyIV catheter assembly shown generally as 700. As shown in FIGS. 1 and 1A,catheter assembly 700 comprises a needle assembly 710 including a needlehub 712 supporting a distally extending needle 718, a safety device 713including a housing 714 and a biasing member 716, and a catheterassembly including a catheter hub 720 and a catheter tube 721 extendingdistally from the catheter hub 720. A proximal end of catheter hub 720may include a luer connector 720 a or the like for releasably securingthe catheter hub 720 to a medical device such as a syringe. The needlehub 712 includes gripping surfaces 770 (FIG. 1) and the catheter hub 720includes a finger engagement member 772 (FIG. 4). Gripping surfaces 770and finger engagement member 772 facilitate manipulation of the catheterassembly 700 and assist in the separation of the catheter hub 720 fromsafety device 713 and needle assembly 710. The gripping surfaces 770 maybe ribbed or include other known slip-resistant features. In aready-to-use position, the housing 714 of the safety device 713 issupported between the needle hub 712 and the catheter hub 720 and theneedle 718 extends from the needle hub 712 through the safety devicehousing 714 and the catheter hub 720 such that a tip 718 a of needle 718projects from a distal end of the catheter tube 721.

Referring also to FIGS. 2A-3, the distal end of needle hub 712 includesa tab 760 (FIG. 3) which is received within a cutout 762 (FIG. 2A)formed in the safety device housing 714 to properly orient the safetydevice 713 in relation to the needle assembly 710 in the ready-to-useposition. Likewise, the safety device housing 714 includes a tab 734 bwhich is received in a slot 720 b (FIG. 7) formed in luer connector 720a of catheter hub 720 to properly orient the safety device 713 inrelation to the catheter assembly 710.

Referring to FIGS. 2A-5, the safety clip housing 714 may be formed frommolded half-sections 714 a and 714 b (FIG. 3). The housing 714 defines adistal opening 724 and a proximal opening 726 which are defined in adistal wall 728 and a proximal wall 730, respectively, of housing 714.Sidewalls 732 enclose a cavity 731. The biasing member 716 is supportedwithin cavity 731 defined by housing 714 between a sidewall 732 andneedle 718 when catheter assembly 700 is in an assembled state. A pairof posts 725 are provided on an inner surface of molded half-section 714a (FIG. 2B). Posts 725 extend across cavity 731 and press a stationaryportion 716 a of biasing member 716 against a sidewall of housing 714 tofixedly secure biasing member 716 within housing 714. In the assembledstate or ready-to-use position of access assembly 700 shown in FIGS.1-5, needle 718 extends through distal and proximal openings 724 and 726of housing 714 and biasing member 716 is compressed between a sidewall732 and needle 718.

Molded half-section 714 b of housing 714 also includes a finger 734(FIG. 5) including a radial projection 734 a which is received in arecess 737 formed in catheter hub 720 to releasably secure safety device713 to catheter hub 720. Finger 734 also extends through a slot 720 b(FIG. 7) formed through luer connector 720 a to properly orient safetydevice 713 in relation to catheter hub 720 when the catheter assembly700 is in an assembled state.

Referring to FIGS. 3-3A, the biasing member 716 includes stationaryportion 716 a, a resilient arm or movable portion 716 b and a blockingarm 716 c. In one embodiment, the biasing member 716 is unitarily formedfrom a resilient material such as spring steel. Alternately, the use ofother methods and materials of construction are envisioned.

In the assembled state of safety IV catheter assembly 700 shown in FIGS.1-5, the stationary portion 716 a of biasing member 716 is fixedly heldwithin cavity 731 of housing 714 by posts 725 which extend from housinghalf-section 714 a towards half-section 714 b and press stationaryportion 716 a against a sidewall 732 of housing half section 714 b.Alternately, biasing member 716 can be secured within cavity 731 ofhousing 714 using other known fastening techniques. Movable portion 716b of biasing member 716 is urged towards stationary portion 716 a viaengagement with needle 718, such that movable portion 716 b ismaintained in a deformed position slidably engaged with needle 718.Blocking arm 716 c is positioned on a top edge 716 d of movable portion716 b and extends beyond movable portion 716 b. See FIG. 3. The blockingarm 716 c is resilient and is maintained in an outwardly deformed statevia engagement with top edge 716 d of movable portion 716 b.

Referring to FIGS. 6-13, when needle assembly 710 is moved proximally inrelation to safety device 713 and needle assembly 710, needle 718 isretracted to withdraw tip 718 a of needle 718 into housing 714. Whenneedle tip 718 a passes through distal opening 724 (FIG. 7) of housing714 of safety device 713, movable portion 716 b of biasing member 716returns to its undeformed state and moves outwardly from stationaryportion 716 a to tilt the housing 714 with respect to needle 718. Morespecifically, due to the inherent characteristics of the resilientmaterial used to form the biasing member 716, movable portion 716 bmoves outwardly from stationary portion 716 a against the needle 718 totilt the housing 714 in relation to the needle 718 such that the distalopening 724 of housing 714 becomes misaligned with the longitudinal axisof needle 718. In the outward or undeformed position of the biasingmember 716, the needle tip 718 a is positioned adjacent distal wall 728of housing 714 offset from distal opening 724. After housing 714 istilted by the biasing member 716, projection 734 a of finger 734 can bemanually disengaged from the recess 737 in catheter hub 720 to releasehousing 714 of safety device 713 from catheter hub 720.

When movable portion 716 b of biasing member 716 moves outwardly ofstationary portion 716 a to a position wherein movable portion 716 bpasses over the end of blocking atm 716 c, blocking arm 716 c returns toits undeformed position between movable portion 716 b and stationaryportion 716 a of biasing member 716 (FIG. 13). More specifically, whenmovable portion 716 b of biasing member 716 moves across cavity beyondthe free end of blocking arm 716 c, blocking arm 716 c moves off of edge716 d of movable portion 716 b downwardly to a position betweenstationary portion 716 a and movable portion 716 b. In this position,blocking arm 716 c prevents movable portion 716 b from moving backtowards stationary portion 716 a and, thus, prevents untilting ofhousing 714 in relation to needle 718. See FIGS. 11 and 13. Bypreventing the housing 714 from untilting, the needle 718 is preventedfrom moving back into alignment with the distal opening 724 to preventthe needle tip 718 a from exiting housing 714 of safety device 713.

As shown in FIGS. 7-12, in one embodiment needle 718 includes a crimp718 b and a bushing 750 slidably positioned about needle 718 proximallyof crimp 718 b. The inside diameter of bushing 750 is larger than theoutside diameter of needle 718 but smaller than the outside diameter ofcrimp 718 b such that bushing 750 is slidably disposed about needle 718proximally of crimp 718 b. In addition, the outer diameter of bushing750 is larger than the inner diameter of proximal opening 726. Thus, asneedle 718 is being withdrawn through proximal opening 726 of housing714, crimp 718 b engages bushing 750 and retracts bushing 750 withneedle 718 proximally until bushing 750 engages proximal wall 730 ofhousing 714 of safety device 713. At this point, engagement betweenbushing 750 and wall 730 will prevent further withdrawal of needle 718through proximal opening 726 of housing 714 to safely retain needle tip718 a within housing 714 of safety device 713. In an alternativeembodiment, the bushing 750 need not be provided and crimp 718 can besized to prevent passage of needle 718 through proximal opening 726.

FIGS. 14-21 illustrate an alternate embodiment of the presentlydisclosed safety IV catheter assembly shown generally as 800. Catheterassembly 800 is similar to catheter assembly 700 in many respects andwill be discussed in detail below.

Catheter assembly 800 comprises a needle assembly 810 including a needlehub 812 supporting a distally extending needle 818, a safety device 813including a housing 814 and a biasing member 816, and a catheterassembly including a catheter hub 820 and a catheter tube 821 extendingdistally from the catheter hub 820. A proximal end of catheter hub 820may include a luer connector 820 a (FIG. 21) or the like for releasablysecuring the catheter hub 820 to a medical device such as a syringe. Theneedle hub 812 includes gripping surfaces 870 (FIG. 21) and the catheterhub 820 includes a finger engagement member 872 (FIG. 14). The fingerengagement member 872 and the gripping surfaces 870 facilitatemanipulation of the assembly 800 and assist in the separation of thecatheter hub 820 from the safety device 813 and the needle assembly 810.The gripping surfaces 870 may be ribbed or include other knownslip-resistant features. In a ready-to-use position or assembled state,the housing 814 of the safety device 813 is supported between the needlehub 812 and the catheter hub 820 and the needle 818 extends from theneedle hub 812 through distal and proximal openings 824 and 826 of thesafety device housing 814 and the catheter hub 820 such that a tip 818 aof needle 818 projects from a distal end of the catheter tube 821.

Referring to FIGS. 14-17, the safety device 813 is similar to safetydevice 713 and includes housing 814 defining a cavity 831 supporting abiasing member 816. Housing 814 may be formed of molded half-sectionswhich are joined together by snap-fitting, welding, or the like. Thebiasing member 816 includes a stationary portion 816 a, a resilient armor movable portion 816 b, a blocking arm 816 c and spring fingers 816 d.The stationary portion 816 a defines a series of openings 880 (FIG. 17)which receive posts 882 (FIG. 16) formed on an inner wall of housing 814within cavity 831. The receipt of posts 882 within openings 880 properlypositions and aligns the stationary portion 816 a of the biasing member816 within the housing 814. One or more of the posts 882 may be heatstaked to secure the biasing member 816 to the posts 882. In addition,an elongated slot 866 (FIG. 17) is provided in stationary portion 816 aof biasing member 816. Elongated slot 866 receives a rib 868 (FIG. 16)formed within housing 814 to also properly position and align biasingmember 816 within cavity 831 of housing 814. Spring fingers 816 d arereceived within a slot 860 (FIG. 15) defined within a C-channel 862positioned in the cavity 831 of housing 814 to secure the biasing member816 within the cavity 831 of housing 814. The inner wall of housing 814also includes ribs 886 (FIG. 16) positioned on opposite sides of theneedle 818 which restrict movement of the needle 818 during and afteractivation of the safety device 813.

As shown in FIG. 17, the blocking arm 816 c is positioned to rest on oneend of movable portion 816 b when the movable portion 816 b is in adeformed state engaged with needle 818. In one embodiment, the end ofmovable portion 816 b includes one or more curved fingers 890 (FIG. 17)which engage the blocking arm 816 c when the needle 818 is in anextended position and movable portion 816 b is biased inwardly towardsstationary portion 816 a to the deformed state by the needle 818. Whenthe needle tip 818 a is withdrawn into housing 814 of the safety device813 such that the needle tip 818 a is pulled through the distal opening824 (FIG. 20) of housing 814, the movable portion 816 b of biasingmember 816 springs outwardly from stationary portion 816 a to a secondposition and tilts the housing 814 with respect to the needle tip 818 a(FIG. 19) to misalign the distal opening 824 of housing 814 from thelongitudinal axis of the needle 818. In the second position of movableportion 816 b, the movable portion 816 b contacts needle 818 and maystill be in compression or may be unstressed. The proximal and or distalopenings 826 and 824 of the safety device housing 814 may be oval shapedto facilitate tilting of the housing 814 in relation to the needle 818.

As shown in FIG. 20, when the movable portion 816 b springs outwardlyfrom stationary portion 816 a, blocking arm 816 c moves off of curvedfinger 890 downwardly to a position between stationary portion 816 a andmovable portion 816 b (FIG. 20). In this position, the blocking arm 816c prevents the movable portion 816 b from moving back to its deformedstate (FIG. 16) to prevent the needle 818 from becoming realigned withthe outlet opening 824.

In one embodiment, the portion of movable portion 816 b of biasingmember 816 which contacts the needle 818 is formed from or covered witha hard slick material 894 (FIG. 17A) to limit drag on the needle 818 asthe needle 818 is withdrawn from the catheter hub 820 into the safetydevice 813. In one embodiment, the material covering the contactingportion of the biasing member is a UV cured adhesive. Alternately, othermaterials having a low coefficient of friction may be provided to coveror construct a portion of the movable portion 816 b to allow needle 818to move over movable portion 816 b of biasing member with minimalfriction or drag.

As shown in FIGS. 18-19, needle 818 includes a crimp 818 b and a bushing850 positioned proximally of crimp 818 b. The inside diameter of bushing850 is larger than the outside diameter of needle 818 but smaller thanthe outside diameter of the crimp 818 b such that bushing 850 isslidably disposed about needle 818 proximally of crimp 818 b but cannotslide distally past the crimp 818 b. At least one wall 898 (FIG. 19) isformed within cavity 831 of housing 814 which is positioned to allowwithdrawal of needle 818 proximally from housing 814 of safety devicebut prevent passage of bushing 850. Thus, as needle 818 is beingwithdrawn through proximal opening 826 of housing 814, crimp 818 bengages bushing 850 and retracts bushing 850 with needle 818 proximallyuntil bushing 850 engages wall 898 of housing 814 of safety device 813.At this point, wall 898 prevents further proximal movement of bushing850 and, thus, needle 818 to prevent further withdrawal of needle 818through proximal opening 826 of housing 814 to safely retain needle tip818 a within housing 814 of safety device 813. In an alternativeembodiment, the bushing 850 need not be provided and crimp 818 can besized to prevent passage of needle 818 past wall 898 or through opening826.

As shown in FIG. 18, housing 814 of safety device 813 also includes afinger 834 having a radial projection 834 a which functions toreleasably secure safety device 813 to catheter hub 820, and a tab 834 bwhich properly orients the safety device 813 in relation to catheter hub820 when the catheter assembly is in an assembled state. Finger 834 andtab 834 b function in the same manner as finger 734 and tab 734 bdescribed above and will not be described in further detail herein.

FIGS. 22-40 illustrate an alternate embodiment of the presentlydisclosed safety IV catheter assembly shown generally as 900. Catheterassembly 900 is similar to catheter assemblies 700 and 800 in manyrespects and will be discussed in detail below.

Referring to FIGS. 22-28, catheter assembly 900 comprises a needleassembly 910 including a needle hub 912 supporting a distally extendingneedle 918, a safety device 913 including a housing 914 and a biasingmember 916 (FIG. 28), and a catheter assembly including a catheter hub920 and a catheter tube 921 extending distally from the catheter hub920. A safety cover 500 is secured to the catheter hub 920 and enclosesthe catheter assembly 900 and needle tip 918 a as will be discussed infurther detail below.

Referring to FIGS. 25-28, a proximal end of catheter hub 920 may includea luer connector 920 a (FIG. 28) or the like for releasably securing thecatheter hub 920 to a medical device such as a syringe. The needle hub912 includes gripping surfaces 970 (FIG. 22) and the catheter hub 920includes a finger engagement member 972 (FIG. 27). The finger engagementmember 972 and the gripping surfaces 970 facilitate manipulation of thesafety IV catheter assembly 900 and assist in the manual separation ofthe catheter hub 920 from the safety device 913 and the needle assembly910. The gripping surfaces 970 may be ribbed or include other knownslip-resistant features. In addition, the needle hub 912 may beergonomically configured to facilitate grasping by a clinician. Forexample, as shown in FIG. 28, the gripping surfaces 970 may have anon-linear, concave configuration.

In a ready-to-use position or assembled state (FIG. 25), the housing 914of the safety device 913 is supported between the needle hub 912 and thecatheter hub 920 and the needle 918 extends from the needle hub 912through distal and proximal openings 924 and 926 (FIG. 30) of the safetydevice housing 914 and the catheter hub 920 such that a tip 918 a ofneedle 918 projects from a distal end of the catheter tube 921.

Referring to FIGS. 22-25 and 35, as discussed above, a safety cover 500is releasably supported on the catheter hub 920 prior to use of thesafety IV catheter assembly 900. The safety cover 500 defines anelongated receptacle 501 (FIG. 35) having a distal portion 502dimensioned to receive the catheter assembly 900 and an enlargedproximal portion 502 a dimensioned to receive a distal end of the needlehub 912 and the safety device 913. The proximal end 504 of the safetycover 500 which defines the proximal portion 502 a of the receptacle 501includes a raised hood 506 on one side and a cutout 508 on the otherside. The raised hood 506 is dimensioned to receive a thumb engagementmember 923 formed on the housing 914 of the safety device 913. Aproximal edge 510 of the safety cover 500 is positioned to engage adistal ledge 915 (FIG. 35) formed on needle hub 912 to releasably securesafety cover 500 to needle hub 912. As shown in FIG. 35, the proximalportion of the receptacle 502 a is dimensioned to receive the housing914 of the safety device 913 in spaced relation such that the inner wall516 of the safety cover 500 does not engage the housing 914. Such anarrangement minimizes the likelihood that removal of safety cover 500from the safety IV catheter assembly will effect separation of thesafety device 913 from the needle hub 912.

As shown in FIGS. 22-25, a distal end of the safety cover 500 defines acircular recess 520 and diametrically opposed notches 522. The circularopening 520 and notches 522 are provided to facilitate molding of thesafety cover 500. More specifically, the circular opening 520 andnotches 522 provide access for passage of a member (not shown) forstabilizing a core during a molding procedure.

Referring to FIGS. 28-31, the safety device 913 is similar to safetydevice 813 and includes housing 914 defining a cavity 931 supporting abiasing member 916. Housing 914 may be formed of molded half-sections914 a and 914 b (FIG. 28) which are joined together by snap-fitting,welding, or the like. In embodiments, one half-section 914 a includesposts 982 which are heat staked within elongated openings 980 formed inthe other half-section 914 b to secure the housing half-sectionstogether (FIG. 40). Alternately, the housing half-sections may be joinedby ultrasonically welding the half-sections together. In one embodiment,half-section 914 b includes recesses 921 a (FIG. 28) which receiveprotrusions 921 b (FIG. 30) on half-section 914 a to properly align thehalf-sections prior to heat staking.

It is noted that the presently disclosed embodiments of the safety IVcatheter are available in different sizes which include needle gaugesizes of 14, 16, 18, 20, 22 and 24. The size of the housinghalf-sections 914 a and 914 b are different in some respects for eachsize safety IV catheter. To ensure that a half-section 914 a of one sizeis not inadvertently connected to a different size half-section 914 b,the posts 982 and openings 980 or the protrusions 921 b and recesses 921a may be selectively positioned to facilitate securement of onlyliked-sized half-sections and prevent securement of different sizedhalf-sections.

The biasing member 916 may be formed from a single piece of resilientmaterial such as spring steel or the like and includes a stationaryportion 916 a, a resilient arm or movable portion 916 b, a blocking arm916 c and spring fingers 916 d. Alternately, the biasing member may beformed from different components joined together using known fasteningtechniques. An elongated slot 966 (FIG. 29) is provided in stationaryportion 916 a of biasing member 916. Elongated slot 966 is dimensionedto receive a rib 968 (FIG. 30) formed within housing half-section 914 ato properly position and align biasing member 916 within cavity 931 ofhousing 914. Spring fingers 916 d are received within a slot 960 (FIG.30) defined within a C-channel 962 positioned in the cavity 931 ofhousing 914 to secure the biasing member 916 within the cavity 931 ofhousing 914. The inner wall of housing 914 b also includes ribs 986(FIG. 28) positioned on opposite sides of the needle 918 which restrictmovement of the needle 918 during and after activation of the safetydevice 913.

As shown in FIG. 36, the blocking arm 916 c is positioned to rest on oneend of movable portion 916 b when the movable portion 916 b is in adeformed state engaged with needle 918. In one embodiment, the end ofmovable portion 916 b includes one or more curved fingers 990 (FIG. 29)which engage the blocking arm 916 c when the needle 918 is in anextended position and movable portion 916 b is biased inwardly towardsstationary portion 916 a to the deformed state by the needle 918. Asshown in FIG. 37-37B, when the needle tip 918 a is withdrawn into cavity931 of housing 914 of the safety device 913 such that the needle tip 918a is pulled through the distal opening 924 (FIG. 39) of housing 914, themovable portion 916 b of biasing member 916 springs outwardly fromstationary portion 916 a to a second position and tilts the housing 914with respect to the needle tip 918 a (FIG. 37 b) to misalign the distalopening 924 of housing 914 from the longitudinal axis of the needle 918.In the second position of movable portion 916 b, the movable portion 916b contacts needle 918 and may still be in compression or may beunstressed. The proximal and/or distal openings 926 and 924 of thesafety device housing 914 may be oval shaped to facilitate tilting ofthe housing 914 in relation to the needle 918.

As shown in FIG. 40, when the movable portion 916 b springs outwardlyfrom stationary portion 916 a, blocking arm 916 c moves off of curvedfingers 990 downwardly to a position between stationary portion 916 aand movable portion 916 b (see also FIG. 28). In this position, theblocking arm 916 c prevents the movable portion 916 b from moving backto its deformed state to prevent the needle 918 from becoming realignedwith the outlet opening 924.

As discussed above with regard to biasing member 816, a portion ofmovable portion 916 b of biasing member 916 which contacts the needle918 may be formed from or covered with a hard slick material, such as aUV cured adhesive, (FIG.) to limit drag on the needle 918 as the needle918 is withdrawn from the catheter hub 920 into the safety device 913.Alternately, other materials having a low coefficient of friction may beprovided to cover or construct a portion of the movable portion 916 b ofbiasing member 916 to allow needle 918 to move over movable portion 916b of biasing member with minimal friction or drag. In addition, themovable portion 916 b may include one or more ribs 925 (FIG. 29)positioned to engage the needle 918 to minimize drag on the needle 918.

As shown in FIGS. 28, 38 and 39, needle 918 includes a crimp 918 b and abushing 950 positioned proximally of crimp 918 b. The inside diameter ofbushing 950 is larger than the outside diameter of needle 918 butsmaller than the outside diameter of the crimp 918 b such that bushing950 is slidably disposed about needle 918 proximally of crimp 918 b butcannot slide distally past the crimp 918 b. At least one wall 998 (FIG.38) is formed within cavity 931 of housing 914 which is positioned toallow withdrawal of needle 918 proximally from housing 914 of safetydevice but prevent passage of bushing 950. Thus, as needle 918 is beingwithdrawn through proximal opening 926 of housing 914, crimp 918 bengages bushing 950 and retracts bushing 950 with needle 918 proximallyuntil bushing 950 engages wall 998 of housing 914 of safety device 913.At this point, wall 998 prevents further proximal movement of bushing950 and, thus, needle 918 to prevent further withdrawal of needle 918through proximal opening 926 of housing 914 to safely retain needle tip918 a within housing 914 of safety device 913. In an alternativeembodiment, the bushing 950 need not be provided and crimp 918 can besized to prevent passage of needle 918 past wall 998 or through opening926.

As best shown in FIGS. 27, 28 and 33, the housing half-section 914 a ofthe safety device 913 includes a curvilinear or radiused finger 934which is positioned to engage a curvilinear or radiused surface 1010formed on the catheter hub 920 to releasably secure the catheter hub 920to the safety device 913. Curvilinear surface 1010 extends through acutout 1010 a formed through the luer connector 920 a. In oneembodiment, each of the radiused finger 934 and the radiused surface1010 includes two or more curvilinear sections which have differentradiuses of curvature. By providing different radiuses of curvature onthe radiused finger 934 and the radiused surface 1010, finger 934 isable to engage the surface 1010 at four points of contact to secure thecatheter hub 920 to the safety device housing 914.

As illustrated in FIG. 38, a bottom surface of radiused finger 934includes a centrally located recess 1030 (FIG. 30). Recess 1030minimizes the contact surface area between finger 934 and surface 1010of catheter hub 920 to reduce friction during separation of the catheterhub 920 from the housing 914 of the safety device 913.

Referring to FIGS. 27 and 28, the housing 914 of the safety device 913also includes a linear finger or tab 934 a. Tab 934 a extends through asecond cutout 1010 b formed through the luer connector 920 a and ispositioned to engage a side of the catheter hub 920 opposite to theradiused surface 1010. Tab 934 a functions to press the catheter hub 920against the radiused finger 934 to provide support to the catheter hub920. The inner surface of tab 934 a includes a central channel 1042(FIG. 28). As such, only the outer edges of tab 934 a engage thecatheter hub 920 at locations outwardly of the centerline of thecatheter hub 920. The housing 914 of the safety device 913 also includesan annular body portion 1050 which surrounds the proximal end of thecatheter hub 920 including the luer connector 920 a to further stabilizethe catheter hub 920 in relation to the safety device 913.

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary embodiments. It is envisioned thatthe elements and features illustrated or described in connection withone exemplary embodiment may be combined with the elements and featuresof another without departing from the scope of the present disclosure.As well, one skilled in the art will appreciate further features andadvantages of the disclosure based on the above-described embodiments.Accordingly, the disclosure is not to be limited by what has beenparticularly shown and described, except as indicated by the appendedclaims.

1-20. (canceled)
 21. A safety device for use with an intravenous catheter assembly comprising: a housing defining a cavity, a distal opening and a proximal opening, the distal and proximal openings being in axial alignment; and a resilient biasing member having a stationary portion, a movable portion and a resilient blocking arm, the movable portion being movable in relation to the stationary portion along a path of movement from a first compressed position to a second position, wherein in the first compressed position the resilient blocking arm is positioned outwardly of the path of movement of the movable portion to allow movement of the movable portion from the first compressed position to the second position and in the second position the resilient blocking arm is positioned between the stationary portion and the movable portion in the path of movement to prevent movement of the movable portion of the movable portion from the second position back to the first position.
 22. The safety device of claim 21, wherein in the second position, the movable portion is spaced further outwardly of the stationary portion than when the movable portion is in the first compressed position.
 23. The safety device of claim 21, wherein the housing includes at least one post extending from one side of the housing across the cavity, the post being positioned to engage the stationary portion of the biasing member to secure the biasing member within the housing.
 24. The safety device of claim 21, wherein the housing of the safety device includes a finger configured to releasably engage the intravenous catheter assembly.
 25. The safety device of claim 24, wherein the finger includes radial projection.
 26. The safety device of claim 21, wherein the biasing member is unitarily formed from a resilient material.
 27. The safety device of claim 26, wherein the resilient material is spring steel.
 28. The safety device of claim 23, wherein the housing is formed from molded half-sections, the at least one post being formed on one of the half-sections and extending across the cavity towards a sidewall of the other of the half-sections.
 29. The safety device of claim 21, wherein a portion of the movable portion includes a material having a low coefficient of friction.
 30. The safety device of claim 24, wherein the finger is radiused. 